Senior Biostatistician (Contract)
Location: South San Francisco, CA
Position type: Contractor, 6 months
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates.
We currently have three protein therapeutics in clinical trials:
- Cabiralizumab (FPA008) –in pigmented villonodular synovitis (PVNS) and in multiple cancers
- FPA144 – in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
We are seeking a contractor to join our Biostatistics and Programming group. This contract position will be responsible for providing biostatistics support for all phases of clinical trials and drug development programs, including regulatory submissions. This individual is also responsible for production of biostatistics deliverables, such as statistical analysis plan and programming specifications in preparing a clinical study report (CSR) or publication, either personally or by supervising CRO statistician(s). This position reports to Director of Biostatistics and Programming.
- Work with clinical scientists, statistical programmers, clinical operations, regulatory affairs, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data
- Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area.
- Produce the following study-related deliverables, either personally or by supervising CROs: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents.
- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
- Provide a sample size based on the specification provided by clinical scientists.
- Develop analysis specifications and review/verify analyses and programming codes for quality assurance.
- Participate in development of standard reporting programs for clinical studies.
- Participate in development of standard CRFs for clinical data collection.
- Participate in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA
- Minimum educational degree is a MS in Statistics, Biostatistics, or Biometrics.
- A minimum of 4 years for Ph.D. (6 years for M.S.) working experience in pharmaceutical and/or Biotech Company.
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS).
- Must have worked on statistical analysis plans, study protocols, clinical study reports, investigator Brochures, and annual reports (or periodic safety update reports).
- Advanced knowledge of theoretical and applied statistics.
- Knowledge of statistical analysis methods and results/data presentation formats of clinical data
- In-depth knowledge of regulatory regulations and guidances.
- Knowledgeable of CDISC requirements for SDTM and ADaM
- Must be highly motivated and able to work well under pressure.
- Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
- Excellent written and interpersonal communication skills
Please upload your cover letter and resume